2. Codex Alimentarius Commission and the International Plant Protection Convention

3. Relationship of CAC and IPPC to the WTO  Two of the “three sisters” named in the SPS Agreement:  Codex Alimentarius Commission = food safety  International Plant Protection Convention = plant health (phytosanitary)  Responsible for “international standards, guidelines, or recommendations (Art 3 Harmonization)  “Members shall…”

4. Standards  Codex Alimentarius (Codex)  International Plant Protection Convention (IPPC)  North American Plant Protection Organization (NAPPO)  ASTM, ISO

5.  Standard setting since 1963  Intergovernmental body-165 members  Not an international treaty  Joint FAO/WHO Secretariat Objectives:  Protecting health of the consumer  Ensuring fair practices in the food trade Codex Alimentarius Commission

6. Food Safety  CONCEPT IS DIFFICULT TO ACCEPT  IPFFI 1970- 1982 Karlsruhe, Germany  International Agencies, National Governments  Feeding studies, 10 kGy  Research showed no indication of radiation- induced carcinogens or other toxic substances  FAO-IAEA-WHO meeting in 1982

7. Conclusions Irradiation of any commodity up to 10 kGy presented: No nutritional problems No toxicological hazard No microbiological problems

9. Codex Alimentarius  Codex General Standard for Irradiated Food (CAC/RS 106- 1979)  Revised 1983  Revised 2003  Code of Practice for the Operation of Irradiation Facilities

10. Codex General Standard  First International Standard for irradiated food  Established requirements for the process  The Code of Practice is considered an “Advisory Text”

11. Codex General Standard  General Requirements:  Radiation Sources  10kGy as the maximum overall average absorbed dose,except when necessary to achieve a legitimate technological purpose  Facilities and control of the Process (according code of practice)  Re-irradiation allowed for products with low moisture

12. Codex General Standard for Irradiated Food  Labeling for the purposes of shipping documents  Labeling of pre-packaged foods requires labeling of whole irradiated foods, of ingredients of foods, and of single ingredient products that have been prepared from irradiated raw ingredients  Optional international symbol: RADURA

13. Code of Practice  Refers to the operation of irradiation facilities ( 60 Co, 137 Cs or X-rays and electrons)  Control of the process: measuring the absorbed radiation dose and monitoring the physical parameters of the process  Irradiation Facilities: parameters, dwell time (or transport speed), bulk density of the material, source-product, geometry  Dosimetry

14. Limiting factors  Petition needed for changes  Codex limited to 10 kGy but may be more if “necessary to achieve a legitimate technological purpose” (CodexStan 106-1983, Rev. 1-2003)

15. IPPC  An international treaty since 1953; Revised in 1973 and 1997  Has its own membership (170)  Not limited to applications in trade  Secretariat in FAO  Harmonization role began with the phytosanitary certificate  Standard setting started in 1993  Currently 29 ISPMs

16. IPPC Standards  Reference, concept, or specific  Usually adopted by consensus of Commission on Phytosanitary Measures (CPM); meets annually  Currently no concept standard for treatments  ISPM No. 18 (irradiation) is the first specific treatment standard

17. Treatment objectives The phytosanitary objective is to achieve the appropriate level of phytosanitary protection. The regulatory objective is to prevent the introduction or spread of regulated pests. The operational objective is to ensure that measures (e.g., treatments) are feasible and efficacious, and applied correctly

18. Effectiveness  Often based on standards for other phytosanitary treatments (e.g., fumigation)  Probit 9 (99.9968% response, usually mortality)  Disadvantages Normally an extremely high level of security Not always possible to work with the large number of pests required for appropriate research

19. New Concept Irradiation is a phytosanitary treatment with different options for a desired response: Inability of insects to emerge or to fly Sterility Inactivation Mortality

20. Situation #1 The pest is sedentary (attached to fruit), is not expected to escape into the environment after treatment, or is not expected to be detected or trigger a regulatory response. Sterility is an acceptable response to provide phytosanitary security while minimizing treatment rigor and the potential for phytotoxic effects.

21. Situation #2 Pest can escape the treated commodity, be detected in the environment, be practically indistinguishable from untreated pests, and trigger a regulatory response. The required response need not be mortality, but must be more than sterility to prevent adult emergence (e.g., fruit flies).

22. Situation #3 Tubers/bulbs for consumption are regulated as propagative material because they can be a pathway for the introduction of serious pests if propagated. The required response can be inactivation to the level of sprout inhibition.

23. Summary  Irradiation is different than other treatments in many ways  Various responses may be possible for irradiation treatment  Regulatory criteria play an important role in deciding the most appropriate response

24. Required Response … a specified level of effect for a treatment (ISPM # 18; Guidelines for the use of irradiation as a phytosanitary measure; IPPC 2003)  An effect (e.g., mortality)  Specified level (e.g., probit 9)

25. ISPM No. 18  Introduction:  Scope, references, definitions and abbreviations and outline of requirements  Technical Requirements:  Authority, treatment objective, treatment, dosimetry, approval of facilities, system integrity, documentation, inspection, research  Two annexes and two appendices:  Annexes: Specific approved treatments; checklist for facility approval  Appendices: Estimates of minimum absorbed dose doses for selected pest groups, research protocol

26. Authority The National Plant Protection Organization (NPPO) is responsible for the evaluation, adoption and use of irradiation as phytosanitary measure

27. Objective  The objective is to prevent the introduction or spread of regulated pests. This may be realized by achieving certain responses from the treatment of targeted pests.  Mortality  Non emergence of adults  Sterility  Inactivation  Efficacy is defined by NPPO of the importing country:  Efficacy concepts:  Description of required response: e.g., sterility  Statistical level of response required, e.g., Probit 9

28. Treatment  Source: 60 Co, 137 Cs, electron beam 10Mev, X-ray 5MeV;  Gy = unit for absorbed dose  Variables: Dose rate, treatment time, temp, humidity, ventilation, modified atmosphere  Dmin: fully attained throughout the commodity  Required response: Mortality (rarely), live target pests may be found after treatment  Application:  as an integral part of packing operation  to bulk unpackaged commodities  at centralized locations such as the port of embarkation  Annex 1 (lists the approved doses)

29. Dosimetry  Ensures that the required Dmin for a particular commodity was delivered to all parts of the consignment  Dosimetry systems should be calibrated according to international/national standards  Components:  Dose mapping  Routine dosimetry

30. Approval of facilities Treatment facilities for phytosanitary treatment must be approved by nuclear regulatory authorities and the NPPO in the country where the facility is located Annex 2: Checklist for facility approval premises, personnel, product handling, irradiation, treatment, packaging and labeling, documentation

31. System Integrity The NPPO is responsible for ensuring system integrity Security at the treatment facility: Treated commodity should be segregated, clearly identified. and handled and safeguard against contamination Labeling: Packages should be labeled with treatment lot numbers,treatment facility, location, dates of packing and treatment Verification: Processes should be verified through monitoring and audits of facility treatments, free access to documentation and records of the treatment facility.

32. Documentation  Documentation of procedures: Consignment handling procedures, configuration of the commodity during treatment, critical process parameters and the means for monitoring, dosimetry, labeling, recordkeeping and documentation requirements  Facility records and traceability: Identification of facility and responsible parties, identity of commodities, treated, purpose of treatment, target regulated pest(s), packer, grower and identification, place of production, quantity in each lot, absorbed doses (target and measured), and date of treatment

33. Inspection/Certification  Export Inspection: documentation verification and examination for non-target pests  Phytosanitary certification: Validates the successful completion of a treatment  Import inspection: the detection of live stages of target pests do not represent treatment failures  Verification for treatment efficacy in export and import: Include laboratory tests or analysis  Administration and documentation: The NPPO has the ability and resources to evaluate, monitor and authorize irradiation for phytosanitary purposes

34. Research Protocol Appendix 2 provides guidance on undertaking research for the irradiation of regulated pests

35. Minimum absorbed doses for pest groups Pest GroupDmin (Gy)Pest GroupDmin (Gy) Aphids and whiteflies (Homopetara) 50- 100Thrips150 -250 Seed weevils70 -300Bores200 -350 Scarab beetles50 -150Spider mites200 -350 Fruit flies50 -250Coleopetra50 -400 Weevils80 -165Lepidoptera100 -1000 Borers100 -280Nematodes~ 4000

36. ISPM No. 18 Trivia  1 st specific standard for risk management  1 st standard for a phytosanitary treatment  Only standard with annexes & appendices  Introduces concept of “required response”  Introduces concept of different endpoints  Introduces concept of system integrity  Completed jointly with IAEA

37. The future  Specific treatments adopted by IPPC  Feasibility studies  Bilateral agreements  Expand tolerance research  Adjustments in regulatory frameworks  Increased consumer acceptance